An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects

NCT03424252 | Completed Phase 1

• 1 other identifier: FDL169-2017-05
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will be randomized to sequentially receive both sublingual and oral formulations of FDL169.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetic parameters, Cmax

  The pharmacokinetic parameters of FDL169; maximal plasma concentration (Cmax)

  7 weeks

• Pharmacokinetic parameters, Tmax

  The pharmacokinetic parameters of FDL169; maximal concentration (Tmax)

  7 weeks

• Pharmacokinetic parameters, AUC

  The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC)

  7 weeks

• Pharmacokinetic parameters, CL/F

  The pharmacokinetic parameters of FDL169; clearance (CL/F)

  7 weeks

• Pharmacokinetic parameters, V/F

  The pharmacokinetic parameters of FDL169; apparent volume of distribution (V/F)

  7 weeks

• Ratio of pharmacokinetic parameters, AUC, between sublingual and oral formulation

  The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC) of FDL169 and its M1 metabolite following sublingual dosing compared to oral dosing

  7 weeks

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  7 weeks

Study Arms (4)

FDL169 Dose Level 1,sublingual to oral

EXPERIMENTAL

Dose level 1 sublingual first and oral second.

Drug: FDL169

FDL169 Dose Level 1 dosing,oral to sublingual

EXPERIMENTAL

Dose level 1 oral first and sublingual second.

Drug: FDL169

FDL169 Dose Level 2 sublingual to oral,Optional

EXPERIMENTAL

Dose level 2 sublingual first and oral second.

Drug: FDL169

FDL169 Dose Level 2 oral to sublingual,Optional

EXPERIMENTAL

Dose level 2 oral first and sublingual second.

Drug: FDL169

Interventions

FDL169 DRUG

Cystic Fibrosis Transmembrane Regulator (CFTR) corrector

FDL169 Dose Level 1 dosing,oral to sublingual; FDL169 Dose Level 1,sublingual to oral; FDL169 Dose Level 2 oral to sublingual,Optional; FDL169 Dose Level 2 sublingual to oral,Optional

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or non-pregnant, non-lactating healthy females
• Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
• Must agree to follow the study's contraception requirement Subject has normal healthy oral mucosa with no clinically significant findings

You may not qualify if:

• Subjects who have received any IMP in a clinical research study within the previous 3 months
• Subjects who have previously received FDL169
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
• Current smokers and those who have smoked within the last 12 months
• Females of childbearing potential who are pregnant or lactating (all female subjects must have a negative urine pregnancy test at screening and each admission). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone \[FSH\] concentration \>40 mIU/mL)
• Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level \>1.5 x upper limit of normal at screening
• Abnormal renal function at screening, defined as estimated glomerular filtration rate \<60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation
• Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in)
• Positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
• Subjects with a history of abdominal surgery eg cholecystectomy (appendectomy is allowed unless procedure was within 12 months)

Sponsors & Collaborators

• Flatley Discovery Lab LLC: lead

Study Sites (1)

Quotient Sciences

Nottingham, NG116JS, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: December 18, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: November 2, 2018

Record last verified: 2018-02

Locations

GB (1)